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upcoming FDA approval for HBsAG quantitative
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upcoming FDA approval for HBsAG quantitative

Thanks to everyone for the valuable information provided here. I've had Hep B for 8 yrs and on ent for 7 yrs. I sero converted to e-antigen negative after 7 months and DNA is undetectable. After reading about the S antigen quantitative test not being available in the US, I started emailing labs and doctors to see if anyone knew where to get this test done. One of the top liver specialists at Georgetown University Hospital in DC emailed that according to his sources, "several companies are due to have their HBsAG quantitative test approved by the FDA in the coming months and we may hear about it in the near future". From what I've read on this forum, I would assume Roche and Abbott would be the companies. So maybe some good news for those of us in the States.
24 Comments Post a Comment
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Avatar m tn
That is very good news. Hopefully it will also be available in Australia too.
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Avatar m tn
what gets measured gets fixed.  This is a good step forward.
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Avatar m tn
Step forward? How many years are they behind here with this test?
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Avatar m tn
I wanted just to comment on this post. We are now in 2015 and FDA didn't approve hbsag quantitative. Any news on when it will be approved?
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Avatar m tn
Any comments guys?
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Avatar m tn
Great news! Can't wait. Been exploring the sending blood to Mexico/India option with no luck. Didn't like the tenuous nature of the option.
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Avatar m tn
I contacted the liver specialist at Georgetown and he had no further info or reason for this still not being approved. Then I contacted Sen. Tim Kaine's office and asked if they could find out from the FDA when this would be approved. FDA gave a ridiculous answer that they couldn't even confirm if the test is under consideration for approval as it might give one company or another some type of financial advantage. Go figure.
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Avatar m tn
what.....they manage financial advantages and care about it more than health and are not ashamed to tell?
if it was my country i d burn down such a thing (i dont have words to describe it)
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Avatar m tn
Thank you jamesdc for following up on this as manybof us here in the states lack this test. I have to wait until december to do my test when i fly to germany.
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Avatar f tn
I don't think that the labs here in USA need the FDA's approval to run this test. When i looked on Labcorps website for the HBV Genotype test i found this comment on the bootom of the page:

Limitations This assay may not be successful when the HBV viral load is <500 IU/mL.
This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.

I emailed them regarding this and surprisingly got a very long response back with their explanation that it's not clinically necessary. I found some research papers concluding that in fact it is and sent it back to them. All they said was basically thanks but no.

So what is the real reason we don't have this test here?
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Avatar m tn
then there is sombody paying and corrupting all labs/doctors not to have the test available....follow the money...who s getting more money from this test being not available?

nucs sellers!

if so the system in US is so corrupt beyond any measure
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Avatar m tn
Stef I dont disagree but thinking

1 is the dna testing more expensive?
2 even on NUCS HBSAG Quant could still be used and charge more money for?

So I think aswell there is certainly something very parculiar about it!
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Avatar m tn
My doctor told me that they feel hbsag quant is useless and FDA will not approve. They say it has no meaning. I live in the USA and not being able to get hbsag quant test is ridiculous. almost the whole world is able to test hbsag quant. the insurance , medical industry and food industry is the most corrupt in the US. food farming industry is so corrupt in the usa its ridiculous.
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Avatar m tn
yes it could be also because hbvdna is very expensive and hbsag very very cheap but  you can t follow therapies by hbsag alone, hbvdna is still needed

hbsag test available could make a lot of damage to nucs market by people switching to peg or stopping nucs if hbsag is low
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Avatar m tn
Studyforhope whats your opinion please?
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Avatar f tn
Scantibodies in California will do the test on research basis for $1,780.00,
they said they don't run this test often and would have to order the reagents in order to do it.
I can't imagine the reagents would cost that much.
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Avatar m tn
Thats absolutely ridiculous
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Avatar f tn
At first they told me they don't do that test, when i pointed out it was listed on their website as one of the services offered that's when they quoted me that price. Yes, it is ridiculous.
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Avatar m tn
7-45€ in italy, free on public healthcare, the machine is the same as that for qualitative and kit to make it quantitative is not that expensive at all, definitely a fraud
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Avatar f tn
For the quoted price we could take a trip to Europe, get it done, and have some fun!  Even if we get it done what will doctors do with it back in the US, since they only care about DNA?  Corrupt system for sure here when it comes to HBV.
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Avatar m tn
even if our hbsag quant was less than 200iu/ml , Doctors in the US would still deny us PEG. In the US we estimate only 2.5 million hep b carriers but i guarantee we pay more for nucs then the estimated 350 million in china.
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Avatar f tn
Agree 100%
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Avatar f tn
True! My GI doctor told me PEG is no longer used in USA even your HBSag is low. I asked the liver specialist about HBSAg quant. test, he said it is not useful.
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Avatar f tn
The health care system in USA is just money making machine. That is why the main focus of treatment is the billing process not taking care of sick people.
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